Surgery, Balloon Dilation Yield Similar Achalasia Outcomes

Action Points

Point out that this study found that achalasia outcomes with laparoscopic myotomy were not superior to those with pneumatic dilation and suggest that graded dilation is a reasonable protocol for pneumatic dilation.

Note that there was a greater need for redilation in patients younger than 40 in the pneumatic-dilation group which may suggest that younger patients should be treated preferentially with laporoscopic myotomy.

﻿Laparoscopic surgery for achalasia achieved results similar to those of pneumatic dilation after two years of follow-up, investigators in a multinational European trial reported.

Both techniques achieved therapeutic success (Eckardt score ≤3) in about 90% of patients. Two years after intervention, patients treated with either technique had similar esophageal sphincter pressure, esophageal emptying, and quality of life, according to Guy E. Boeckxstaens, MD, PhD, of University Hospital of Leuven in Belgium, and colleagues.

"Our results are in line with one smaller randomized study that also showed no significant between-group difference in the success rate in the intention-to-treat analysis," they wrote in the May 12 New England Journal of Medicine.

"A cross-sectional follow-up evaluation of an achalasia cohort at the Cleveland Clinic Foundation also showed similar rates of treatment success with pneumatic dilation and laparoscopic Heller's myotomy," they noted.

Achalasia results from the absence of esophageal peristalsis, combined with a defective relaxation of the lower esophageal sphincter. Current treatment options consist primarily of endoscopic pneumatic dilation or laparoscopic Heller's myotomy.

With the introduction of minimally invasive surgical techniques, interest in the surgical approach has increased, the authors noted. Several single-center studies showed therapeutic success rates of 89% to 100%, boosting enthusiasm for surgical intervention.

Currently, physician preference dictates the choice of treatment, the authors continued. Previous studies had different protocols and outcome measures, complicating efforts to compare results among the trials.

In an effort to resolve the uncertainty about the relative efficacy of the two interventions, investigators at 14 hospitals in five European countries performed a randomized comparison of pneumatic dilation and laparoscopic Heller's myotomy with fundoplication.

Standard clinical protocols were used for both interventions.

All patients randomized to pneumatic dilation underwent at least two dilations, one to three weeks apart. A 30-mm balloon was used for the first dilation and a 35-mm balloon for the second.

If symptoms recurred after two years, a third dilation was permissible. Recurrence within two years was considered treatment failure.

In the surgery arm, treatment failure was defined as symptom recurrence after surgery, associated with an Eckardt score >3.

The primary outcome of the trial was therapeutic success, assessed one and two years after intervention. Secondary endpoints included need for retreatment, lower esophageal sphincter pressure, esophageal emptying on a barium esophagogram, quality of life, and complications.

The one-year success rates were 90% with pneumatic dilation and 93% with surgery.

At two years, 86% of patients in the pneumatic dilation arm and 90% of patients in the surgery arm met the criteria for treatment success.

Neither difference achieved statistical significance.

With respect to secondary outcomes at two years, esophageal sphincter pressure averaged 10 mm Hg in the surgery arm and 12 mm Hg with pneumatic dilation, esophageal emptying was 1.9 cm in the surgical arm and 3.7 cm with balloon dilation, and quality-of-life scores were similar in the two groups.

Additionally, 15% and 23% of patients had abnormal exposure to esophageal acid in the pneumatic dilation and surgery groups, respectively.

No statistically significant between-group differences emerged from either the intention-to-treat or per-protocol analysis.

However, there was a greater need for redilation in patients younger than 40 in the pneumatic-dilation group which the authors said may suggest that "younger patients (especially men) should be treated preferentially with laparoscopic myotomy."

"On the basis of our data, we conclude that laparoscopic Heller's myotomy with Dor's fundoplication does not result in rates of therapeutic success that are superior to those with pneumatic dilation for the primary treatment for achalasia, at least after a mean follow-up period of 43 months," the authors wrote in their concluding observations.

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